Biosafety Regulatory Reviews and Leeway to Operate: Case Studies From Sub-Sahara Africa.

While modern biotechnology and, specifically, genetic modification are subject of debate in many parts of the world, an increasing number of countries in Sub-Sahara Africa are making important strides towards authorizing general releases of genetically modified (GM) crop varieties for use by farmers and agribusinesses. Obviously, the documented economic and environmental benefits from planting GM crops-based on a track record of over two decades-are a major driver in the decision-making process. Another key factor is the increasing alignment of biosafety regulatory policies with progressive agricultural and rural development policies in Africa, resulting in-compared to past experiences-greater emphasis on anticipated benefits rather than risks in biosafety regulatory reviews. In several cases, this has led to expedited reviews of GM crop release applications, either for confined field trials or general environmental release, taking experiences and data from other countries into account. Such regulatory approaches hold promise as the pipeline of relevant, pro-poor GM crop applications is expanding as are the opportunities provided by novel plant breeding techniques. This review article analyses the shifting policy context in select African economies, resulting in adoption of new agricultural technology, and novel regulatory approaches used in biosafety decision-making. Case studies will be presented for Ghana, Kenya, Malawi, Nigeria and Uganda to analyze challenges, distill lessons learned and to present general policy recommendations for emerging economies.

Readiness for Environmental Release of Genetically Engineered (GE) Plants in Uganda.

Research and development of genetically engineered (GE) crops in Uganda was initiated in 2003 with the launch of a national agricultural biotechnology center at Kawanda in central Uganda. The country has now approved 17 field experiments for GE plants, which were first established in 2006 with the planting of a banana confined field trial that evaluated performance of plants modified to express resistance to black sigatoka disease. Researchers leading the GE experiments have indicated that some of these GE plants are ready for environmental release that is moving beyond confined field testing toward commercialization. The government of Uganda, over the past two decades, has supported processes to put in place an effective national biosafety framework including establishment of a supportive policy environment; creation of a clear institutional framework for handling applications and issuance of permits; building critical capacity for risk analysis; and providing options for public engagement during decision-making. Uganda is ready to make a biosafety decision regarding environmental release of GE plants based on the level of capacity built, progress with priority GE crop research in the country, and the advancement in biosafety systems. Enactment of a national biosafety law that provides for a coordinated framework for implementation by the relevant regulatory agencies will strengthen the system further. In addition, product developers need to submit applications for biosafety approval for environmental release of GE crops so that mechanisms are tested and improved through practice.